A complex of immunoglobulin and histamine has been known as a drug preparation, histamine-added immunoglobulin. It restores histamine fixing ability which is lowered in patients suffering from allergy and asthma. Accordingly, histamine-added immunoglobulin is used as an agent for nonspecific hyposensitizing therapy for bronchial asthma, allergic rhinitis, vasomotor rhinitis, and allergic skin diseases such as urticaria, chronic eczema, atopic dermatitis, etc. Histamine-added immunoglobulin also exhibits suppressive action to liberation of histamine. It does not exhibit side effects exhibited by antihistamines and adrenocortical hormones used as symptomatic remedies. It has therefore been widely used as a pharmaceutical agent with high safety. See pages 463 and 464 of "Drugs in Japan, Ethical Drugs," edited by Japan Pharmaceutical Information Center; published by Yakugyo Jiho Co., Ltd., Japan in October 1996.
Histamine-added immunoglobulin is administered by a hypodermic injection because it is a proteinic preparation. There has been no report of its pharmaceutical effects by oral administration.
The present inventors have conducted various tests and studies on the pharmacological activity of histamine-added immunoglobulin. As a result, they have unexpectedly found that said histamine-added immunoglobulin has the same pharmacological activity as shown by the conventional hypodermic injection even if it is administered orally whereupon the present invention has been achieved.
The present invention provides a pharmaceutical composition for oral administration containing histamine-added immunoglobulin as an active component. The composition is shelf-stable over an extended period of time and is easily administered by a patient. The histamine-added immunoglobulin may be administered orally for the treatment of allergic diseases such as bronchial asthma, allergic rhinitis, vasomotor rhinitis, urticaria, chronic eczema and atopic dermatitis; autoimmune diseases such as multiple sclerosis, chronic rheumatoid arthritis and systemic lupus erythematodes; various immunodeficiency syndromes; and also eosinophilia or various inflammatory diseases caused by infectious diseases, parasitic diseases, diseases of respiratory organs, autoimmune diseases, malignant tumor, etc.